Description: At OSUCCC, the stimulus for protocol development comes from the Disease Specific Committees. Priorities for accrual to studies are also set by the Committees. Individuals seek design advice and formatting help from the Interdisciplinary Oncology Unit in the preparation of proposals for submission to both the Scientific Review Committee (SRC) of the Center, and the Institutional Review Board (IRB), which are separate entities. Investigators can choose to send their proposal either the SRC or the IRB first. Investigators may appear to defend their study and outside consultants are appropriate. The SRC monitors the progress of each institutional study for accrual on a regular basis. There are clearly defined stopping rules and the SRC appears to have the authority to implement them. The quality of data is audited by an Audit Committee whose minutes were supplied for review to the site visitors. This committee meets monthly and reviews a random selection of charts for protocol compliance. The Institution is in the process of establishing an office to monitor clinical studies that will have overarching responsibilities to assure quality of data.